# K211851: Ora-Aid

- Pathway: 510(k) (Traditional)
- Applicant: Tbm Corporation
- Decided: Jan 11, 2022 after 210 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K103054 (2011). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110750: Periopatch, Mis Implants Technologies, Ltd. (2011) Summary page 4.

## Most influential descendants
- K253816: MuCover (proposed name) Oral Wound Dressing (2026), 0 descendants of its own

## Indications for use
Intra-oral Wound Dressing is intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa, including stomatitis, minor chafing and traumatic ulcers, abrasions caused by braces and ill-fitting dentures, and lesions associated with oral surgery. Intra-oral Wound Dressing operates to relieve pain by adhering to and protecting affected tissues from further irritation, thereby allowing healing.

Source page: https://510kreport.com/device/K211851
Methodology: https://510kreport.com/methodology